Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.
Bowel ultrasound
+ magnetic resonance enterography (MRE)
Digestive System Diseases+3
+ Gastroenteritis
+ Gastrointestinal Diseases
Diagnostic Study
Summary
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 18 years of age or younger Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography. Exclusion Criteria: Subjects with suspected or newly diagnosed Crohn disease Subject who have the following in their body may not undergo MRE imaging: Metal chips/shrapnel Surgical clips Artificial joints Metallic bone plates Prosthetic devices Heart pacemakers Clips in or around the eye balls artificial heart valves Bullet fragments Chemotherapy or insulin pumps
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Michigan Hospital
Ann Arbor, United StatesOpen University of Michigan Hospital in Google Maps